510(k) Report

Devices descending from K894844

764 later devices reach Bonefit Implant System Accessories & Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+8K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+8K142260NobelActiveNobel Biocare AB201599—
+8K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+8K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+8K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+8K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+9K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+9K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+9K240977DenQ Sub SLA Implant SystemDenq20240—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+9K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+9K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+9K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+9K231913T-FITTechwin Co., Ltd.20240—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K222976MU SystemDentis Co., Ltd.20230—
+9K220517IBS SystemInnobiosurg Co., Ltd.20220—
+9K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+9K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+9K220252High Retention Attachment SystemZest Anchors, LLC20221—
+9K210559ATOZ Mini-ScrewMk Meditech, Inc.20210—
+9K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+9K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+9K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+9K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd.20200—
+9K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+9K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+9K190552JJ Implant SystemJj Implants20190—
+9K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+9K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+9K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+9K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+10K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+10K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+10K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K241032BellaTek BarsBiomet 3i, LLC20241—
+10K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+10K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+10K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+11K260940BellaTek BarsZimVie US Corp, LLC20260—
+11K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+11K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+11K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+12K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+13K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—